FDA approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The agency previously granted Priority Review and orphan drug designations for Onivyde.
The effectiveness of Onivyde was demonstrated in a phase III, three-arm, randomized, open label study of 417 patients (NAPOLI-1) with metastatic pancreatic adenocarcinoma whose cancer had grown after receiving gemcitabine or a gemcitabine-based therapy. The study was designed to determine whether patients receiving Onivyde plus fluorouracil/leucovorin or Onivyde alone lived longer than those receiving fluorouracil/leucovorin. The monotherapy regimen in this study did not achieve its primary endpoint and, therefore, Onivyde is not indicated as a single agent.
Patients treated with Onivyde plus fluorouracil/ leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only fluorouracil/ leucovorin (p=0.014, unstratified HR=0.68, 95% CI: [0.50-0.93]). There was no survival improvement for those who received only Onivyde compared to those who received fluorouracil/leucovorin.
In addition, patients receiving Onivyde plus fluorouracil/leucovorin had a delay in the amount of time to tumor growth compared to those who received fluorouracil/leucovorin. The average time for those receiving Onivyde plus fluorouracil/leucovorin was 3.1 months compared to 1.5 months for those receiving fluorouracil/leucovorin.
The safety of Onivyde was evaluated in 398 patients who received either Onivyde with fluorouracil/ leucovorin, Onivyde alone or fluorouracil/leucovorin. The most common side effects of treatment with Onivyde included diarrhea, fatigue, vomiting, nausea, decreased appetite, inflammation in the mouth and fever. Onivyde was also found to result in lymphopenia and neutropenia. Death due to sepsis following neutropenia has been reported in patients treated with Onivyde. The labeling for Onivyde includes a boxed warning to alert health care professionals about the risks of severe neutropenia and diarrhea. Onivyde is not approved for use as a single agent for the treatment of patients with metastatic pancreatic cancer.
Onivyde is marketed by Merrimack Pharmaceuticals Inc.
